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Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05658510
Recruitment Status : Recruiting
First Posted : December 20, 2022
Last Update Posted : March 28, 2023
Sponsor:
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
BioXcel Therapeutics Inc

Study Description
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Brief Summary:
In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder. This study compares the study drug to a placebo.

Condition or disease Intervention/treatment Phase
Agitation,Psychomotor Bipolar I Disorder Bipolar II Disorder Schizophrenia Schizoaffective Disorder Schizophreniform Disorders Drug: BXCL501 Drug: Matching Placebo Phase 3

Detailed Description:
This is a randomized, double-blind, placebo-controlled, 2-Part, Phase III study to assess the efficacy, safety, and tolerability of a 60 mcg dose of BXCL501 in adult (18-75 years old) males and females with agitation episodes associated with a primary diagnosis of bipolar I disorder, bipolar II disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder. Part 1 of the study is a one-day, in-clinic treatment, and post-treatment observation period with patients experiencing an acute episode of agitation. Part 2 of the study is a 12-week study to determine the safety of BXCL501 when used as needed for episodes of agitation at home.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients randomized to receive 60 mcg of BXCL501 or a matching placebo.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy And Safety of BXCL501 Evaluated For At-Home Use In A Multisite Double-Blind Placebo-Controlled Trial For Agitation Associated With Schizophrenia And Bipolar Disorder
Actual Study Start Date : November 21, 2022
Estimated Primary Completion Date : March 30, 2024
Estimated Study Completion Date : March 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: 60 mcg of BXCL501
Sublingual film containing 60 Micrograms Dexmedetomidine
 Drug: BXCL501
Sublingual Film
Other Name: Dexmedetomidine
Placebo Comparator: Part 1: Matching Placebo
Sublingual Placebo film
 Drug: Matching Placebo
Sublingual Placebo Film
Other Name: Placebo
Experimental: Part 2: 60 mcg of BXCL501
Sublingual film containing 60 Micrograms Dexmedetomidine
 Drug: BXCL501
Sublingual Film
Other Name: Dexmedetomidine
Placebo Comparator: Part 2: Matching Placebo
Sublingual Placebo film
 Drug: Matching Placebo
Sublingual Placebo Film
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Part 1: Change from baseline in Positive and Negative Syndrome Scale - Excited (PEC) total score [ Time Frame: 2 hours ]
    The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)

  2. Part 2: Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Through study completion, an average of 12 weeks ]
    To assess the safety of BXCL501 when used at-home based on treatment-emergent adverse events (TEAEs)

  3. Part 2: Incidence of serious adverse events (SAEs) [ Time Frame: Through study completion, an average of 12 weeks ]
    To assess the safety of BXCL501 when used at-home based on serious adverse events (SAEs)


Secondary Outcome Measures :
  1. Part 1: Clinical Global Impression - Improvement (CGI-I) [ Time Frame: 2 hours ]
    The Clinical Global Impression - Improvement (CGI-I) for agitation in response to treatment measures the current level of agitation relative to the level of agitation prior to administration of study intervention. The CGI-I scores range from 1 to 7 with a score of 1 indicating very much improved, and a score of 7 indicating very much worse.

  2. Part 1: Change in Modified Clinical Global Impression - Severity (mCGI-S) scores from Baseline [ Time Frame: 2 hours ]
    The Modified Clinical Global Impression - Severity (mCGI-S) measures the current level of agitation. For this study, the mCGI-S is a 4-point scale where a score of 0 represents no agitation, and scores of 1-3 describe increasing severities of agitation (mild, moderate, severe).

  3. Part 1:The number of responders based on the Modified Clinical Global Impression - Severity (mCGI-S) score [ Time Frame: 2 hours ]
    The Modified Clinical Global Impression - Severity (mCGI-S) measures the current level of agitation. A responder is characterized as a participant with a score of 0 (represents no agitation) or 1 (mild agitation)

  4. Part 1:Change from baseline in Agitation-Calmness Evaluation Scale (ACES) [ Time Frame: 2 hours ]
    The Agitation-Calmness Evaluation Scale (ACES) is a single item scale that measures overall agitation and sedation, where a score of 1 indicates marked agitation; 2 - moderate agitation; 3 - mild agitation; 4 - normal behavior; 5 - mild calmness; 6 - moderate calmness; 7 - marked calmness; 8 - deep sleep; and 9 - unarousable.

  5. Part 1: Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Through study completion, an average of 8 hours ]
    To assess the safety of BXCL501 based on treatment-emergent adverse events (TEAEs)

  6. Part 1: Change from baseline in heart rate (HR) at rest [ Time Frame: Baseline, and 2, 4, 6, and 8 hours postdose ]
    The effect of BXCL501 on heart rate at rest

  7. Part 1: Change from baseline in heart rate (HR) under orthostatic stress [ Time Frame: Baseline, and 2, 4, 6, and 8 hours postdose ]
    The effect of BXCL501 on heart rate under orthostatic stress

  8. Part 1: Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at rest [ Time Frame: Baseline, and 2, 4, 6, and 8 hours postdose ]
    The effect of BXCL501 on systolic and diastolic blood pressure at rest

  9. Part 1: Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) under orthostatic stress [ Time Frame: Baseline, and 2, 4, 6, and 8 hours postdose ]
    The effect of BXCL501 on systolic and diastolic blood pressure under orthostatic stress

  10. Part 1: Incidence of abnormal electrocardiograms (ECG) reported as an adverse event (AE) [ Time Frame: Through study completion, an average of 8 hours ]
    Any abnormal ECG value that is reported as an adverse event (AE)

  11. Part 1: Incidence of abnormal clinical laboratory values reported as an adverse event (AE) [ Time Frame: Through study completion, an average of 8 hours ]
    Any abnormal clinical laboratory value that is reported as an adverse event (AE)

  12. Part 2: Change from baseline in Modified Clinical Global Impression - Severity (mCGI-S) [ Time Frame: 2 hours ]
    The Modified Clinical Global Impression - Severity (mCGI-S) measures the current level of agitation. For this study, the mCGI-S is a 4-point scale where a score of 0 represents no agitation, and scores of 1-3 describe increasing severities of agitation (mild, moderate, severe).

  13. Part 2: The number of responders based on the Modified Clinical Global Impression - Severity (mCGI-S) score [ Time Frame: 2 hours ]
    The Modified Clinical Global Impression - Severity (mCGI-S) measures the current level of agitation. A responder is characterized as a participant with a score of 0 (represents no agitation) or 1 (mild agitation)

  14. Part 2: Number and frequency of agitation episodes [ Time Frame: Through study completion, an average of 12 weeks ]
    The absolute number and frequency of reported agitation episodes will be analyzed descriptively

  15. Part 2: Percentage of all treated episodes of agitation satisfying the definition of m-CGI-S responder [ Time Frame: 2 hours after each treatment for an episode of agitation ]
    The Modified Clinical Global Impression - Severity (mCGI-S) measures the current level of agitation. A responder is characterized as a participant with a score of 0 (represents no agitation) or 1 (mild agitation)

  16. Part 2: Number of interactions with emergency services related to agitation episodes [ Time Frame: Through study completion, an average of 12 weeks ]
    The number of reported interactions with emergency services (specifically hospitalization, emergency room visits, urgent care clinic visits, and law enforcement intervention) due to episodes of agitation will be analyzed descriptively


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

A patient may enroll in only one part of the study; either Part 1 or Part 2.

Inclusion Criteria:

  • Male and female patients between the ages of 18 to 75 years, inclusive
  • Patients who can read, understand and provide written informed consent.
  • Patients who have met Diagnostic and Statistical Manual5/5-Text Revision criteria for bipolar I or bipolar II disorder, schizophrenia, schizoaffective or schizophreniform disorder.
  • Patients who, in the opinion of the Principal Investigator, are in good general health before study participation based on a detailed medical history, a physical examination, a 12-lead ECG, a blood chemistry profile, hematology, and urinalysis.
  • Participants who agree to use a medically acceptable and effective birth control method

Part 1 only

  • Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PEC.
  • Patients with a score of ≥4 on at least 1 of the 5 items on the PEC at Baseline.

Part 2 only

  • Patients have had at least one clinical presentation of agitation requiring an intervention in the past month
  • The patient has an Informant who can read, understand, and provide written informed consent and understand and follow the study procedures

Exclusion Criteria:

  • Patients with serious or unstable medical illnesses.
  • A history of agitation episodes due to substance use.
  • A diagnosis of antisocial personality disorder, borderline personality disorder, or narcissistic personality disorder that predated the diagnosis of schizophrenia or bipolar disorder
  • Patients who are judged to be at significant risk of suicide
  • Female patients who have a positive pregnancy test at Screening or Baseline, or are breastfeeding.
  • Patients currently treated with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin), alpha-2 adrenergic agonists, or other prohibited medications.
  • Patients with hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease, or focal neurological findings.
  • History of syncope or other syncopal attacks, current evidence of hypovolemia, or orthostatic hypotension
  • Patients with laboratory or ECG abnormalities considered clinically significant by the Investigator
  • Patients who have received an investigational drug within 30 days before the study start
  • Patients who have previously received BXCL501 in either a clinical trial or via prescription
  • Patients considered by the Investigator to be unsuitable candidates for receiving dexmedetomidine or considered to be unsuitable for participating in the study for any reason.

Part 1 only

  • Patients with agitation caused by acute intoxication, including identification of alcohol by breathalyzer or drugs of abuse (except for THC) during urine screening.
  • Use of benzodiazepines or other hypnotics or antipsychotic drugs in the 4 hours before study treatment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05658510


Contacts
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Contact: Stephen Gorny 475-228-2016 sgorny@bioxceltherapeutics.com
Contact: Carl Gommoll, MS 475-355-5177 cgommoll@bioxceltherapeutics.com

Locations
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United States, Arkansas
BioXcel Clinical Research Site 112 Recruiting
Little Rock, Arkansas, United States, 72211
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
BioXcel Clinical Research Site 119 Recruiting
Little Rock, Arkansas, United States, 72211
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
United States, California
BioXcel Clinical Research Site 113 Recruiting
Bellflower, California, United States, 90706
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
BioXcel Clinical Research Site 110 Recruiting
Culver City, California, United States, 90230
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
BioXcel Clinical Research Site 108 Recruiting
Garden Grove, California, United States, 92845
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
BioXcel Clinical Research Site 117 Recruiting
Lemon Grove, California, United States, 91945
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
BioXcel Clinical Research Site 121 Recruiting
Los Angeles, California, United States, 90015
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
BioXcel Clinical Research Site 104 Recruiting
Orange, California, United States, 92868
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
BioXcel Clinical Research Site 114 Recruiting
Riverside, California, United States, 92506
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
United States, Georgia
Bioxcel Clinical Research Site 106 Recruiting
Atlanta, Georgia, United States, 30331
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
BioXcel Clinical Research Site 107 Recruiting
Decatur, Georgia, United States, 30030
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
United States, Illinois
BioXcel Clinical Research Site 109 Recruiting
Chicago, Illinois, United States, 60640
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
United States, Maryland
BioXcel Clinical Research Site 103 Recruiting
Gaithersburg, Maryland, United States, 20877
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
United States, New Jersey
BioXcel Clinical Research Site 105 Recruiting
Berlin, New Jersey, United States, 08009
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
BioXcel Clinical Research Site 101 Recruiting
Marlton, New Jersey, United States, 08053
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
United States, Texas
BioXcel Clinical Research Site 102 Recruiting
DeSoto, Texas, United States, 75115
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
Sponsors and Collaborators
BioXcel Therapeutics Inc
Worldwide Clinical Trials
Investigators
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Study Chair: Robert Risinger, MD BioXcel Therapeutics
More Information
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Responsible Party: BioXcel Therapeutics Inc
ClinicalTrials.gov Identifier: NCT05658510    
Other Study ID Numbers: BXCL501-401
First Posted: December 20, 2022    Key Record Dates
Last Update Posted: March 28, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psychomotor Agitation
Disease
Schizophrenia
Bipolar Disorder
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Mood Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
 Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action